PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD

Pacemaker Lead Adaptor

PACESETTER SYSTEMS

The following data is part of a premarket notification filed by Pacesetter Systems with the FDA for Pacesetter Systems, Endocardial Firm Lead.

Pre-market Notification Details

Device IDK850652
510k NumberK850652
Device Name:PACESETTER SYSTEMS, ENDOCARDIAL FIRM LEAD
ClassificationPacemaker Lead Adaptor
Applicant PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar,  CA  91342
ContactNestor Kusnierz
CorrespondentNestor Kusnierz
PACESETTER SYSTEMS 12884 BRADLEY AVE. Sylmar,  CA  91342
Product CodeDTD  
CFR Regulation Number870.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-19
Decision Date1985-04-10

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